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Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis in Non-pregnant Women

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ClinicalTrials.gov Identifier: NCT03752112
Recruitment Status : Not yet recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Melanie Taylor, World Health Organization

Brief Summary:

Hypotheses The antibiotic, Cefixime, for use in non-pregnant women with early syphilis will be efficacious and safe.

Primary Objective The primary objective of the study is to demonstrate the efficacy, as measured by a 4 fold decrease in Rapid Plasma Reagin (RPR) titer from baseline to 6 months after treatment, with Cefixime 400mg taken orally two times a day for 10 consecutive days.

Secondary Objective The secondary objective of the study is to determine the safety, as measured by the number of grade 3 or greater toxicities experienced, using the NIH/NCI toxicity score, during or after treatment with Cefixime 400mg taken orally two times a day for 10 consecutive days.


Condition or disease Intervention/treatment Phase
Syphilis Female Drug: Cefixime Drug: Benzathine penicillin 2.4 million units Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a Phase 1/2 trial to evaluate the efficacy and safety of cefixime for use in treating women with acute syphilis.

This is a randomized, non-comparative, open label study assessing the efficacy and safety of cefixime 400mg taken orally two times a day for 10 consecutive days in non-pregnant women with early syphilis infection.To benchmark the performance of benzathine penicillin in the study population being used for cefixime, The investigators will include a contemporary arm of participants that will receive standard of care treatment with benzathine penicillin according to the Brazil national STI treatment guidelines. The investigators will use a ratio of 2 patients receiving cefixime to 1 patient receiving benzathine penicillin.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis in Non-pregnant Women
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : February 1, 2021


Arm Intervention/treatment
Experimental: Cefixime
cefixime 400mg taken orally two times a day for 10 consecutive days in non-pregnant women with early syphilis infection.
Drug: Cefixime
Cefixime 400mg taken orally two times a day for 10 consecutive days in non-pregnant women with early syphilis infection
Other Name: Intervention

Benzathine penicillin
To benchmark the performance of benzathine penicillin in the study population being used for cefixime, the investigators will include a contemporary arm of participants that will receive standard of care treatment with benzathine penicillin according to the Brazil national STI treatment guidelines. The investigators will use a ratio of 2 patients receiving cefixime to 1 patient receiving benzathine penicillin.
Drug: Benzathine penicillin 2.4 million units
Benzathine penicillin 2.4 million units: The investigators will include a contemporary arm of participants that will receive standard of care treatment with Benzathine penicillin 2.4 million units according to the Brazil national STI treatment guidelines. The investigators will use a ratio of 2 patients receiving cefixime to 1 patient receiving benzathine penicillin.This non-comparator arm of benzathine penicillin will be included to account for study population differences in terms of stage of disease, history of prior infection, experience of re-infection, experience of serofast state, or other co-factors that could impact serological response
Other Name: Standard treatment




Primary Outcome Measures :
  1. Quantitative RPR titer change [ Time Frame: 6 months following last dose of Cefixime 400 mg ]
    RPR titer response at 6 months


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE with cefixime [ Time Frame: Daily after the first dose of cefixime 400mg orally through 10 days after the first dose ]
    Number of participants with treatment-related adverse events as assessed by CTCAE. Information on side effects will be collected daily for 10 days of administration of cefixime using a pre-established list of most commonly reported side effects and a grade scale will be applied using the Common Terminology Criteria for Adverse Events.

  2. The number of participants reporting tolerability of cefixime [ Time Frame: Daily after the first dose of cefixime 400mg orally through 10 days after the first dose and qualitative overall assessment of tolerability measured via questionnaire 14 days after the first dose of cefixime ]
    Tolerability: The number of participants reporting tolerability of cefixime as measured by quantitative reported experience of common side effects and qualitative experience of tolerance of the regimen as collected through daily questionnaires and an end treatment questionnaire at 14 days after the first dose of cefixime.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on biologic gender
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female, 18 years of age or older
  2. Non-pregnant
  3. Able to provide informed consent
  4. Test positive for syphilis with a positive TPPA AND an RPR titer equal to or greater than 1:8
  5. Non-cephalosporin allergic
  6. Non-penicillin allergic
  7. Agree to be called once a day by study staff to be reminded to take study drug
  8. Able to swallow pills
  9. Willing to attend follow-up visits at 3, 6, and 9 months after completion of the study treatment
  10. Willing to take oral contraceptive or use condom to prevent pregnancy during the study period
  11. HIV negative

Exclusion Criteria:

1) Female under 18 years of age 2) HIV positive 3) Pregnancy test positive or clinical pregnancy 4) Prior history of syphilis or syphilis treatment within 6 months of study screening 5) Allergy to penicillin or cephalosporins (including allergy to cefixime) 6) In the judgment of the interviewer, has a medical condition or other factor that might affect their ability to follow the protocol 7) Previous enrollment in the study 8) Presenting a condition that would not allow reliable informed consent (alcohol abuse or substance misuse) 9) Lacking mental capacity to give informed consent to participation


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752112


Contacts
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Contact: Melanie M Taylor, MD +41 22 791 2172 mtaylor@who.int
Contact: Edna O Kara, MD +41 22 791 2649 karae@who.int

Locations
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Brazil
Fortaleza University Not yet recruiting
Fortaleza, Ceara, Brazil
Contact: Alix Araujo, PhD       alix.araujo@hotmail.com   
Contact: Ivo Castell Branco Coelho, MD       ivo@ufc.br   
Principal Investigator: Alix Araujo, PhD         
Principal Investigator: Mariangela Silveira, MD         
Principal Investigator: Angelica Miranda, MD         
Sponsors and Collaborators
World Health Organization
Investigators
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Principal Investigator: Melanie M Taylor, MD World Health Organization
Study Director: Nathalie JN Broutet, MD World Health Organization
Study Chair: Edna O Kara, MD World Health Organization

Publications:
WHO. WHO guidelines for the treatment of Treponema pallidum (syphilis). http://wwwwhoint/reproductivehealth/publications/rtis/syphilis-treatment-guidelines/en/. 2016.
U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES. National Institutes of Health National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 . https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/Archive/CTCAE_4.0_2009-05-29_QuickReference_8.5x11.pdf

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Responsible Party: Melanie Taylor, Medical Offier, World Health Organization
ClinicalTrials.gov Identifier: NCT03752112     History of Changes
Other Study ID Numbers: ERC0003096
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Beginning 9 months and ending 24 months following article publication, the supporting information that will be shared for IPD are all data that underlie the results in the publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Beginning 9 months and ending 24 months following article publication,
Access Criteria:
  • Access will be provided to investigators whose proposed use of data has been approved by an independent review committee identified for this purpose
  • Data whose goal is to achieve aims in the approved proposal
  • The way proposals should be submitted will be decided and informed after WHO standard operating procedure (in development) for this purpose is complete.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Melanie Taylor, World Health Organization:
Syphilis
Women
Cefixime
Brazil
Sexually Transmitted Infection
STI

Additional relevant MeSH terms:
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Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Syphilis
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Infection
Penicillins
Cefixime
Penicillin G Benzathine
Penicillin G
Penicillin G Procaine
Anti-Bacterial Agents
Anti-Infective Agents